FDA Adverse Event Injury Summary report: N

TRACHEAL TUBE

MDR report key: 7055 · Received October 29, 1993

Report

Report Number
7055
Event Type
Injury
Date Received
October 29, 1993
Date of Event
October 18, 1993
Report Date
October 25, 1993
Manufacturer
MALLINCKRODT CRITICAL CARE
Product Code
BTR
Adverse Event
Yes
Report Source
User Facility report

Narratives

Description of Event or Problem · 1

PT WENT INTO RESPIRATORY DISTRESS REQUIRING INTUBATION ON 10/18/93. PT INTUBATED DURING A CODE BLUE PROCEDURE. ATTEMPTED BY HOUSE PHYSICIAN AND RESPIRATORY THERAPIST AND FINALLY INTUBATED BY ANESTHESIOLOGIST. PT ABDOMEN BECAME DISTENDED AFTER INTUBATION. SURGICAL CONSULT OBTAINED AND SURGICAL INTERVENTION ON 10/18/93 FOR REPAIR OF RUPTURED HG PERFORATION ESOPHAGEAL GASTRIC JUNCTION SECONDARY TO TEAR. PRE-OP DX = COPD. MAXIMUM LENGTH OF E-T TUBE = 12 INCHES. TEAR WAS AT THE LESSER CURVATURE E-G JUNCTION OF STOMACH AND NOT LIKELY FROM INTUBATION. PT HEMODYNAMIC STATUS AND PREDISPOSING CONDITION MAY HAVE BEEN A CAUSAL FACTOR OF THE TEAR. PT DID WELL POST-OPERATIVELY.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: MAYBE. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 TRACHEAL TUBE LOW CONTOUR TRACHEAL TUBE CUFFED MURPHY I 7 1/2 BTR MALLINCKRODT CRITICAL CARE UNKNOWN UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 73 YR Required Intervention